Vertebral compression fracture, stable type, without neurological deficit Musculoskeletal Diseases
Conditions
Interventions
Evaluation of qualitative and quantitative of pre-, peri- and post-operative data. Comparison between pre-and post-operative values provided by radiological parameters, pain medication, VAS, ODI and S
Sponsors
Spineart (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Presenting one or more three stable vertebral fractures at non-adjacent levels, fractures type A1.1, A1.2, A1.3, A2 (gap between fragments less than 2 mm) and A3.1, A3.2, A3.3 according to Magerl classification 3. Presenting vertebral traumatic fracture(s), due to high-energy trauma, or osteoporotic fall of one's own height 4. Able to understand the investigation protocol, agree with the investigation plan, and complete the necessary documents 5. Who voluntarily signed the informed consent form
Exclusion criteria
Exclusion criteria: 1. Anterior treatment with cyphoplasty at the fractured level 2. Unstable fractures of type B or C according to Magerl 3. Size of the pedicules incompatible with safe access to the instrument
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Risks are measured by the incidence of perioperative complications and safety reporting and post-operative risks (adverse events reporting, radiological assessments at 6, 12 and 24 months) 2. Restoration of vertebral height (mm) and reduction of kyphosis (Cobb Angle) at the level operated is measured by comparing radiological images pre-surgery, perioperative, immediate post-surgery, at 6-, 12- and 24-months post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Volume of cement injected and cement distribution (vertebral and horizontal) is measured (in ml) at surgery 2. Effectiveness of the system is measured by the duration of post-operative hospitalization 3. Pain is evaluated by changes in the use of pain medication and the visual analogue score (VAS) score pre-surgery, immediate post-surgery, at 6-, 12- and 24-months post-surgery 4. Quality of life is measured using the SF-12 questionnaire preoperatively, immediate postoperatively and at 6, 12 and 24 months and time between intervention and back to work 5. Functional evaluation using Oswestry Disability Index (ODI) score preoperatively, immediate postoperatively and at 6, 12 and 24 months | — |
Countries
France
Outcome results
None listed